Influenza Clinical Trial
Official title:
Evaluation of the Safety, Reactogenicity and Immunogenicity of FluBlok Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly to Healthy Children Aged 6 To 59 Months
The purpose of this study was to evaluate dose-related safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine, administered to healthy children aged 6 to 59 months.
Status | Completed |
Enrollment | 156 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 59 Months |
Eligibility |
Inclusion Criteria: 1. The subject was: 1. aged 6-59 months old (inclusive) at enrollment. 2. in good health (and not on any chronic medications), as determined by medical history and a history directed targeted physical examination. 3. naïve for previous influenza vaccination prior to study enrollment. 2. Parents or guardians must: 1. be able to understand and comply with planned study procedures and be available for all study visits. 2. provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate. Exclusion Criteria: 1. a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex. 2. a history of severe asthma or more than three previous wheezing episodes. 3. be undergoing immunosuppression as a result of an underlying illness or treatment. 4. an active neoplastic disease or a history of any hematologic malignancy. 5. be using oral or parenteral steroids, inhaled steroids or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this study. 6. a history of receiving influenza vaccine or plans during the study to receive influenza vaccine outside the study. 7. a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study. 8. received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study. 9. have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (these conditions include, but are not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients). 10. a history of severe reactions following immunization. 11. an acute illness, including an axillary temperature greater than 100.0*F, within 3 days prior to vaccination. 12. received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 6-month study period. 13. any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. 14. a history of Guillain-Barré syndrome. 15. be participating concurrently in another clinical trial (either in active phase or in follow-up phase). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Kentucky pediatric /Adult Research | Bardstown | Kentucky |
United States | Primary Physicians Research | Pittsburg | Pennsylvania |
United States | Saint Louis University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Protein Sciences Corporation |
United States,
King JC Jr, Cox MM, Reisinger K, Hedrick J, Graham I, Patriarca P. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy c — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of safety and reactogenicity of FluBlok and TIV in healthy children aged 6-59 months | influenza season | Yes | |
Secondary | To compare the immunogenicity after each dose of two different formulations of FluBlok to TIV in healthy children aged 6-35 months and one formulation of FluBlok to TIV in healthy children aged 36-59 months. | Day 0, 28, 56 | No |
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